Neonatal TPN Starter Bags Recalled for Unassured Sterility
Central Admixture Pharmacy Services is recalling 135 bags of neonatal TPN starter bags distributed nationwide because the FDA found inadequate assurance of sterility during inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with no reported illnesses or injuries. The hazard involves potential microbial contamination due to unassured sterility in an intravenous product for neonates, a vulnerable population. No actual harm has been documented, placing this at the High severity level per the rubric.
Plain-English summary
Central Admixture Pharmacy Services, Inc. is recalling 135 bags of Neonatal TPN Starter Bag containing Trophamine 2% / Dextrose 10% with low calcium and Heparin (250 mL per bag). The product was distributed nationwide.
The recall was initiated after an FDA inspection determined that the sterility of these injectable products could not be adequately assured. Sterility is a critical requirement for medications intended for intravenous administration, especially to neonatal patients.
Affected lots are 37-894712 (expires 04/30/2023), 37-897924 (expires 05/13/2023), and 37-899606 (expires 05/20/2023). Healthcare providers and pharmacies should stop using these lots immediately. Patients who received products from these lots should contact their healthcare provider.
The recalled product
- Product
- Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 10% with low calcium and HEPARIN, packaged in 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0425-1.
- Manufacturer
- Central Admixture Pharmacy Services, Inc.
- Hazard
- sterility-assurance
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot # 37-894712
- Exp 04/30/2023
- 37-897924
- Exp 05/13/2023
- 37-899606
- Exp 05/20/2023
Distribution
Distributed nationwide across the United States.
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